Glenmark Pharmaceuticals announced on Thursday that it has received approval from the US Food and Drug Administration to market a generic medication to treat plaque psoriasis. The US Food and Drug Administration (USFDA) has granted final approval to Glenmark Pharma for Calcipotriene and Betamethasone Dipropionate Foam, the generic version of Leo Pharma’s Enstilar.
The USFDA stated that the Mumbai-based pharmaceutical company was the first to receive paragraph IV certification for Calcipotriene and Betamethasone Dipropionate Foam in an abbreviated new drug application (ANDA). “As a result of this approval, Glenmark is eligible for 180 days of generic drug exclusivity for Calcipotriene and Betamethasone Dipropionate Foam,” the pharmaceutical company explained.